Abstract
<h3>BACKGROUND</h3> In patients with severe symptomatic aortic stenosis (AS), transcatheter aortic valve replacement (TAVR) is approved for use across the entire spectrum of risk, including low surgical risk patients. TAVR has been shown to provide rapid improvement in quality-of-life while being less invasive than surgical aortic valve replacement (SAVR). In Canada, TAVR funding is limited, and the perceived higher cost of TAVR may be a barrier to expanding the therapy to low-risk patients. While TAVR has been shown to be cost-effective, the affordability of implementing TAVR for low-risk AS patients from the hospital's payers' perspective is not known. <h3>METHODS AND RESULTS</h3> A budget impact analysis was conducted using a one-year time horizon to quantify the total cost of healthcare resource utilization to initially treat low-risk AS patients and the subsequent management of adverse events (AEs). Micro-costing was performed for both self-expandable TAVR and SAVR based on resource utilization (operating room time, supplies, intensive care unit (ICU) and total length of stay (LOS)) and complication event rates (heart failure (HF) hospitalization, pacemaker implantation, stroke, acute kidney injury) from the recently published Evolut Low-Risk CoreValve trial. Overall differences in cost between TAVR and SAVR were calculated for 100 patients for various scenarios of TAVR uptake (0% to 70%) in low-risk AS patients. Costs were obtained from provincial datasets and the published literature (reported in 2021 Canadian dollars). The mean procedural cost of SAVR and TAVR per patient was $41,405 and $44,061, respectively. The one-year cost of managing AEs for SAVR and TAVR were $4,883 and $4,398, respectively (difference = $485). Overall, the incremental difference in cost was $2,172 higher with TAVR at one year per patient. The total cost of care for a hypothetical cohort of 100 low-risk AS patients in the base-case scenario (10% TAVR, 90% SAVR) was $4,650,357. The proportion of TAVR/SAVR was increased incrementally to a final scenario (70% TAVR, 30% SAVR) where the total cost of care was $4,780,612 representing a 2.8% increase in cost. One-way sensitivity analysis on key variables showed that the main contributors to the cost difference were the ICU LOS (difference in cost: -3.1% to 3.2%) and HF hospitalization rates (2.8% to 3.9%). <h3>CONCLUSION</h3> Despite the higher upfront procedure cost, the incremental cost of implementing TAVR in low-risk severe symptomatic aortic stenosis patients was small due to relatively lower adverse events rates at one year. In severe aortic stenosis management, a shift from SAVR to TAVR is likely affordable.
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